Bridge to Life Secures First FDA Clearance for Hypothermic Oxygenated Perfusion System in Liver Transplantation
Key Insights
Bridge to Life (search)'s VitaSmart HOPE System (search) receives FDA De Novo clearance, becoming the first hypothermic oxygenated perfusion device cleared for liver transplantation (search) in the United States.
The FDA-cleared labeling supports use in both donation after brain death and donation after circulatory death donors, with no specified maximum perfusion duration limit.
Clinical evidence from the Bridge to HOPE pivotal trial enrolled 219 recipients across 15 U.S. transplant centers and demonstrated statistically significant improvements in early graft function.
Bridge to Life (search) Ltd. has achieved a regulatory milestone with the U.S. Food and Drug Administration granting De Novo clearance for the VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System, establishing the first regulatory classification for hypothermic oxygenated perfusion in liver transplantation (search) in the United States. The clearance enables commercial use of VitaSmart for hypothermic oxygenated perfusion of donor livers following static cold storage and prior to transplantation.
"This clearance represents a transformational milestone for Bridge to Life (search) and an important advancement for liver transplantation (search) in the United States," said Don Webber, CEO and President of Bridge to Life Ltd. "VitaSmart is the first FDA-cleared hypothermic oxygenated perfusion system for liver transplantation, and the labeling reflects FDA's determination of safety and effectiveness, aligned with real-world transplant practice."
Expanding Access to DCD Liver Grafts
The FDA-cleared labeling supports hypothermic oxygenated perfusion of donor livers prior to transplantation in both Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donors, within defined donor criteria. DCD donors represent one of the most significant opportunities to expand the available donor pool in liver transplantation (search), according to the company.
"Having an FDA-cleared hypothermic oxygenated perfusion system commercially available represents an important development for transplant programs," said Kristopher Croome, MD, Professor of Surgery and Transplant and Hepatobiliary Surgeon at Mayo Clinic Florida (search). "The availability of VitaSmart's HOPE technology under FDA-cleared labeling, supports ongoing efforts to optimize preservation strategies, particularly with DCD liver grafts."
Clinical Flexibility Without Duration Limits
A key feature of the FDA clearance is that the indication does not specify a maximum machine perfusion duration, allowing clinicians to apply hypothermic oxygenated perfusion within the scope of the indication using clinical judgment and established protocols. Extended HOPE duration provides operational and patient safety advantages, including improved coordination of transplantation logistics, avoidance of rushed implantation, and reduced risk of re-exposure to static cold ischemia.
Dr. Croome noted that "without a fixed perfusion duration limitation this represents an important advancement and underscores the FDA's recognition of hypothermic oxygenated perfusion as a safe and clinically meaningful approach to liver preservation, empowering transplant teams with greater flexibility to deliver the best possible care to patients in need."
Pivotal Trial Results Support Clearance
FDA clearance was supported by data from the Bridge to HOPE pivotal clinical trial, a multicenter, randomized controlled study conducted in the United States evaluating end-ischemic portal venous hypothermic oxygenated perfusion in adult liver transplantation (search). The study enrolled 219 recipients across 15 U.S. transplant centers, including extended-criteria donor populations in both DBD and DCD grafts.
The statistically significant clinical results of the trial formed the basis for FDA's De Novo determination and demonstrated improvements in early graft function with a strong safety profile, according to the company.
Commercial Launch and Market Positioning
Bridge to Life (search) plans to initiate the U.S. commercial launch of VitaSmart during the first quarter of 2026. The company has appointed David Castiglioni as Chief Commercial Officer to lead the U.S. commercialization of VitaSmart and support continued growth across the company's proprietary solutions portfolio.
Within the scope of its cleared use, VitaSmart is designed to support improved organ utilization, reduced downstream resource utilization, simplified workflow integration without the need for transport-based perfusion, and a capital-efficient, scalable approach to advanced organ preservation. The system provides a center-friendly, non-transport-based approach to hypothermic oxygenated perfusion that positions it as a commercially scalable and economically compelling platform capable of broad adoption across U.S. transplant programs.
Technology and Implementation
VitaSmart delivers hypothermic oxygenated perfusion by cooling donor livers to controlled hypothermic temperatures while providing oxygenated perfusate prior to transplantation. The system is engineered for reliability, simplicity, and ease of use, supporting adoption across a wide range of transplant center environments under its FDA-cleared indication.
Bridge to Life (search) Ltd. is a global leader in organ preservation solutions, offering a comprehensive portfolio that includes Belzer UW (search), EasiSlush (search), and the VitaSmart Hypothermic Oxygenated Perfusion System. The company partners with transplant centers and organ procurement organizations worldwide to advance preservation science and support life-saving transplantation.